Animal NDC 13744-101-01 Douxo Calm

Animal Product Information

Field Name Field Value
Animal NDC Code 13744-101-01
Proprietary Name Douxo Calm What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Douxo Calm What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Ceva Sante Animale
Product Type Otc Animal Drug
Usage Information
    INDICATIONS: For use on dogs and cats only. For the management of skin inflammation.DIRECTIONS FOR USE: Shake well before use. Spray directly on the skin by holding the pump approximately 8 inches from the skin. Apply once a day or as directed by your veterinarian.
Active Ingredient(s)
  • Salicyloyl Phytosphingosine
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • BIOSACCHARIDE GUM-4 (9XRL057X90)
  • BUTYLENE GLYCOL (3XUS85K0RA)
  • PEG-8 DIMETHICONE (GIA7T764OD)
  • GLYCERIN (PDC6A3C0OX)
  • MINERAL OIL (T5L8T28FGP)
  • RASPBERRY SEED OIL (9S8867952A)
  • ISOSTEARYL ALCOHOL (Q613OCQ44Y)
  • COCONUT OIL GLYCERETH-8 ESTERS (9V234MGT7F)
  • ETHYLCELLULOSES (7Z8S9VYZ4B)
  • CYCLOMETHICONE 5 (0THT5PCI0R)
  • DIMETHICONE (92RU3N3Y1O)
  • TOCOPHEROL (R0ZB2556P8)
  • SODIUM DEHYDROACETATE (8W46YN971G)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (59TL3WG5CO)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • SODIUM HYDROXIDE (55X04QC32I)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • SODIUM HINOKITIOL (5MPS47D679)
  • MASOPROCOL (7BO8G1BYQU)
  • WATER (059QF0KO0R)
  • BIOSACCHARIDE GUM-4 (9XRL057X90)
  • BUTYLENE GLYCOL (3XUS85K0RA)
  • PEG-8 DIMETHICONE (GIA7T764OD)
  • GLYCERIN (PDC6A3C0OX)
  • MINERAL OIL (T5L8T28FGP)
  • RASPBERRY SEED OIL (9S8867952A)
  • ISOSTEARYL ALCOHOL (Q613OCQ44Y)
  • COCONUT OIL GLYCERETH-8 ESTERS (9V234MGT7F)
  • ETHYLCELLULOSES (7Z8S9VYZ4B)
  • CYCLOMETHICONE 5 (0THT5PCI0R)
  • DIMETHICONE (92RU3N3Y1O)
  • TOCOPHEROL (R0ZB2556P8)
  • SODIUM DEHYDROACETATE (8W46YN971G)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (59TL3WG5CO)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • SODIUM HYDROXIDE (55X04QC32I)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • SODIUM HINOKITIOL (5MPS47D679)
  • MASOPROCOL (7BO8G1BYQU)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Douxo Calm Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



DOUXO®

Calm Gel

Phytosphingosine salicyloyl 0.20%

ACTIVE INGREDIENTS: Phytosphingosine salicyloyl 0.20%

INGREDIENTS: Water, Biosaccharide Gum-4, Butylene Glycol, PEG-8, Glycerin, Paraffinum Liquidum, Rubus Idaeus (Raspberry) Seed Oil,  Isostearyl Alcohol, Butylene Glycol Cocoate, Ethylcellulose, Cyclopentasiloxane, Dimethicone, Tocopherol, Sodium Dihydroacetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 80, Sodium Hydroxide, Phenoxyethanol, Hinokitiol, Nordihydroguaiaretic Acid.


Indications & Usage



INDICATIONS: For use on dogs and cats only. For the management of skin inflammation.

DIRECTIONS FOR USE: Shake well before use. Spray directly on the skin by holding the pump approximately 8 inches from the skin. Apply once a day or as directed by your veterinarian.


Precautions



CAUTIONS: For external use in dogs and cats only. Avoid contact with the eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult your veterinarian.


Warnings



WARNING: Keep out of the reach of children.


Storage And Handling



STORAGE CONDITIONS: Store at room temperature. Do not freeze.


Other



Authorized for sale through licensed veterinarians only.

Manufactured for Ceva Animal Health, LLC

Lenexa, KS 66215 | 1-800-999-0297

Douxo® is a registered trademark of Sogeval S.A.

©2015 Ceva Animal Health, LLC


Principal Display Panel - 60 Ml (2 Ounce) Bottle



DOUXO®

Calm Gel

Phytosphingosine salicyloyl 0.20%

Allergies

60 mL (2 fl. oz.)

CEVA


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.